NIH RADx Data Hub

Study Information

dbGaP Study Accession: phs003373

NIH Institute/Center: NIDDK

RADx Data Program: RADx-UP

DOI: 10.60773/ybnk-xd66

Release Date: 12/06/2023

Study Description: The Georgia Center for Diabetes Translation Research Center (P30DK111024) proposed to leverage its interdisciplinary expertise (clinicians, implementation and behavioral scientists, public health, technology, and diabetes experts) and collaborations (community, academic, government, and health system partners) to rapidly scale a COVID-19 testing program for adults and children who are at high risk due to background metabolic disease (i.e., diabetes, obesity, or elevated risk of diabetes). The Rapid Optimization of COVID-19 Testing for People Affected by Diabetes program adapted, optimized, and iteratively evaluated and refined a testing and education strategy delivered through the network of Federally-Qualified Health Center (FQHC) partners. This study focused on Georgia, a national epicenter of diabetes, which is experiencing rapidly escalating COVID-19 cases, morbidity, and mortality. Yet, the state has not accelerated testing opportunities, leaving critically underserved subgroups at high-risk without access to testing. Building on technologies and innovations designed by the team, this study addressed access gaps, optimized resource allocation to meet high risk groups where it suits them best, and supported people at the time of and after their test results. Guided by the EPIS framework, the implementation program learned how to scale the strategy, combining approaches to reach high-risk groups through testing enhancement at FQHC partner sites and other community testing centers with a "test your bubble" approach to provide opportunities for all household members to get tested. To achieve this, geospatial analyses were conducted to identify localities of testing deserts within counties with high densities of people at risk for COVID-19 infection, hospitalization, and mortality (Aim 1; Exploration); engage community and clinic stakeholders to formatively understand what barriers and facilitators influence testing and what strategies are well-received by users (Aim 2; Preparation); develop models that provide real-time guidance on whom to test, where to test, and when to test (Aim 3; Preparation); and deploy and evaluate the program at testing site partners using rapid-cycle testing in a pre-post effectiveness-implementation type 2 hybrid study (Aim 4; Implementation). Sustainability will be measured through continuous quality improvement efforts (Aims 2, 4) and future research. Data from this study motivated further programs and studies of how to scale serological testing and vaccination (in the future) and has huge relevance for underserved areas of other states. The study evaluated this program in terms of its reach, effectiveness, adoption, implementation, and maintenance (REAIM). The team had extensive experience applying these transformative innovations to reach populations. The project team leveraged partnerships with the Georgia Department of Public Health, nationally-recognized expertise via the NIH-funded Rapid Acceleration of Diagnostics Validation Core at Emory University, National COVID-19 Resiliency Network at Morehouse's School of Medicine, and the Georgia Clinical and Translation Science Alliance's Community Engagement Program.

Updated Date: 04/17/2024

Principal Investigator: Narayan, Kabayam M Venkat

Has Data Files: Yes

Study Domain: Comorbidities; Serological (Antibody) Testing; Community Outreach Programs; Vaccination Rate/Uptake; Testing Rate/Uptake; Rapid Diagnostic Test (RDT)

Data Collection Method: Interview or Focus Group; Survey

Keywords: Prediabetes; Diabetes; Obesity; High-risk Populations

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

Study Sites: Georgia Institute of Technology; Morehouse School of Medicine

Data Types: Clinical; Behavioral; Family History; Social; Questionnaires/Surveys

Study Start Date: 09/21/2020

Study End Date: 07/31/2023

Species: Human Data

Estimated Cohort Size: 10000

Study Population Focus: Rural Communities; Older Adults or Elderly; Adults; Children; Underserved/Vulnerable Population; Lower Socioeconomic Status (SES) Population; African American; Hispanic and Latino

Acknowledgement Statement: This study was supported through funding, 3P30DK111024-05S1, for the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as part of the RADx-UP program. We would like to thank the Georgia Diabetes Translation Research Center (GDTRC), Atlanta Center for Microsystems Engineered Point-of-Care Technologies (ACME POCT), Morehouse School of Medicine’s National Infrastructure for Mitigating the Impact of COVID-19 within Racial and Ethnic Minority Communities (NIMIC), Morehouse School of Medicine’s Prevention Research Center (PRC), Georgia CTSA, Emory Healthcare, Children’s Hospital of Atlanta, Grady Health, and the Georgia Federally Qualified Health Center network. Approved users should acknowledge the provision of data access by dbGaP for accession phs003373.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: PA-20-135

NIH Grant or Contract Number(s): 3P30DK111024-05S1

Consent/Data Use Limitations: General Research Use

Study Documents

Study Documents Table
Document	Document Name	File Size	Download
Study Documentation	phs003373_Project 5_Protocol.pdf	1.22 MB
README	project5_README.html	281.59 KB

Data Files

Total Files: 6

Data Files: 2

Metadata Files: 2

Dictionary Files: 2

Study Datasets Table
File Name	File Type	File Format(s)	# of Records	# of Variables	Metadata	Dictionary
project5_DATA_origcopy.csv	Tabular Data - Non-harmonized	csv	10109
project5_DATA_transformcopy.csv	Tabular Data - Harmonized	csv	10109